Physicians Coalition for Injectable Safety Responds To Kansas Actions On Lipodissolve
September 5, 2007 The Physicians Coalition for Injectable Safety today announced their full support of recent actions by the Kansas State Board of Healing Arts greatly restricting the use of LipoDissolve, a controversial fat-dissolving injection.
In action taken Saturday, August 18, the Kansas Board said patients must not receive LipoDissolve unless it is authorized by a physician as part of an investigational drug trial (http://www.ksbha.org/agendas/07-0705-reg.htm). The restrictions are expected to take effect September 15, 2007.
The Coalition, formed by the American Society for Aesthetic Plastic Surgery, The American Academy of Facial Plastic and Reconstructive Surgeons and the American Society of Ophthalmic Plastic and Reconstructive Surgery is an alliance aimed at protecting consumer safety as it relates to cosmetic injectable treatments. The Kansas position, according to the Coalition, is appropriate and significant in protecting consumer safety and restricting treatment of non-FDA approved, compounded, injectable substances into the human body.
The Coalition reminds consumers that to date, no formal studies of mesotherapy or LipoDissolve demonstrate efficacy or safety and cautions that reports of complications include skin infection, disfigurement, severe cramping, bloating and dehydration. Consumers in all 50 states should take note of the Kansas actions, which are, to date, the most appropriate in protecting consumer health and safety with an unproven and widely marketed treatment.
"A formal clinical trial requires a specific informed consent process," states Coalition spokesperson Julius Few, MD, associate professor, plastic surgery at Northwestern University Feinberg School of Medicine, in Chicago, Ill. "Anyone undergoing this treatment should be specifically informed by the treating doctor that it is not FDA approved. In addition, the treating doctor must state all the potentially known complications and the patient must accept the fact that many unknown complications may occur."
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, and the American Society of Ophthalmic Plastic and Reconstructive Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS), founded in 1967, is the leading professional organization of plastic surgeons certified by the American Board of Plastic Surgery who specialize in cosmetic plastic surgery. With 2,100 members in the U.S., Canada, and many other countries, ASAPS is at the forefront of innovation in aesthetic plastic surgery around the world.
The American Academy of Facial Plastic and Reconstructive Surgery is the world's largest specialty association that represents over 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA), and holds an official seat in both the AMA House of Delegates and the American College of Surgeons board of governors. AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck.
The American Society of Ophthalmic Plastic and Reconstructive Surgery represent surgeons qualified in plastic surgery of the eyelids and surrounding facial structures. Fellows of the Society are board certified in ophthalmology, have completed fellowships in oculoplastic surgery (currently two years), and perform aesthetic, plastic, and reconstructive surgery of the face, orbits, eyelids, and lacrimal system.